Acquired immunodeficiency syndrome (UPDATE 2000)
The Canadian Medical Association has developed the following general principles to serve as guidelines for various bodies, health care professionals and the general public. Specific aspects of infection with human immunodeficiency virus (HIV) and acquired immunodeficency syndrome (AIDS) that relate to physicians' ethical responsibilities as well as society's moral obligations are discussed. Such matters include: the need for education, research and treatment resources; the patient's right to investigation and treatment and to refuse either; the need to obtain the patient's informed consent; the right to privacy and confidentiality; the importance of infection control; and the right to financial compensation in the case of occupational exposure to HIV.
Physicians should keep their knowledge of AIDS and HIV infection up to date.
Physicians should educate patients and the general public in the prevention of AIDS by informing them of means available to protect against the risk of HIV infection and to avoid further transmission of the virus.
Health authorities should maintain an active public education program on AIDS that includes the school population and such initiatives as public service announcements by the media.
All levels of government should provide resources for adequate information and education of health care professionals and the public on HIV-related diseases; research into the prevention and treatment of HIV infection and AIDS; and the availability and accessibility of proper diagnosis and care for all patients with HIV infection.
HIV antibody testing
Physicians have an ethical responsibility to recommend appropriate testing for HIV antibody and to care for their patients with AIDS or refer them to where treatment is available.
Physicians should provide counselling to patients before and after HIV antibody testing.
Because of the potential psychologic, social and economic consequences attached to a positive HIV test result, informed consent must, with rare exceptions, be obtained from a patient before testing. However, the CMA endorses informed mandatory testing for HIV infection in cases involving the donation of blood, body fluids or organs.
The CMA recognizes that people who have doubts about their serologic status may avoid being tested for fear of indiscretion and therefore supports voluntary non-nominal testing of potential HIV carriers on request.
The CMA supports the Canadian Blood Service and Hema-Québec in their programs of testing and screening blood donations and blood products.
Confidentiality in reporting and contact tracing
The CMA supports the position that cases of HIV infection should be reported non-nominally with enough information to be epidemiologically useful. In addition, each confirmed case of AIDS should be reported non-nominally to a designated authority for epidemiologic purposes.
The CMA encourages attending physicians to assist public health authorities to trace and counsel confidentially all contacts of patients with HIV infection. Contact tracing should be carried out with the cooperation and participation of the patient to provide maximum flexibility and effectiveness in alerting and counselling as many potentially infected people as possible.
In some jurisdictions physicians may be compelled to provide detailed information to public health authorities. In such circumstances, the CMA urges those involved to maintain confidentiality to the greatest extent possible and to take all reasonable steps to inform the patient that their information is being disclosed.
The CMA Code of Ethics (article 22) advises physicians that disclosure of a patient’s HIV status to a spouse or current sexual partner may not be unethical and, indeed, may be indicated when physicians are confronted with an HIV-infected patient who is unwilling to inform the person at risk. Such disclosure may be justified when all of the following conditions are met: the partner is at risk of infection with HIV and has no other reasonable means of knowing of the risk; the patient has refused to inform his or her sexual partner; the patient has refused an offer of assistance by the physician to do so on the patient's behalf; and the physician has informed the patient of his or her intention to disclose the information to the partner.
The CMA stresses the need to respect the confidentiality of patients with HIV infection and consequently recommends that legal and regulatory safeguards to protect such confidentiality be established and maintained.
Health care institutions and professionals should ensure that adequate infection-control measures in the handling of blood and body fluids are in place and that the rights of professionals directly involved in patient care to be informed of and protected from the risks of HIV infection are safeguarded.
The CMA does not recommend routine testing of hospitalized patients.
The CMA urges appropriate funding agencies to assess the explicit and implicit costs of infection control measures and to ensure that additional funds are provided to cover these extraordinary costs.
Occupational exposure and the health care professional
Health care workers should receive adequate financial compensation in the case of HIV infection acquired as a result of accidental occupational exposure.
Physicians and other health care providers with HIV infection have the same rights as others to be protected from wrongful discrimination in the workplace and to be eligible for financial compensation for work-related infection.
Physicians with HIV infection should consult appropriate colleagues to determine the nature and extent of the risk related to their continued involvement in the care of patients.
Appropriateness in Health Care
This paper discusses the concept of appropriateness in health care and advances the following definition:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
Building on that definition it makes the following policy recommendations:
* Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
* Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
* Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
As health systems struggle with the issue of sustainability and evidence that the quality of care is often sub-optimal, increasing attention is focused on the concept of appropriateness. A World Health Organization study published in 2000 described appropriateness as "a complex, fuzzy issue"1. Yet if the term is to be applied with benefit to health care systems, it demands definitional clarity. This policy document presents the Canadian Medical Association definition of appropriateness which addresses both quality and value. The roots of the definition are anchored in the evolution of Canadian health care over the last two decades. The document then considers the many issues confronting the operationalization of the term. It concludes that appropriateness can play a central role in positive health system transformation.
At the Canadian Medical Association General Council in 2013 the following resolution was adopted:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
This definition has five key components:
* right care is based on evidence for effectiveness and efficacy in the clinical literature and covers not only use but failure to use;
* right provider is based on ensuring the provider's scope of practice adequately meets but does not far exceed the skills and knowledge to deliver the care;
* right patient acknowledges that care choices must be matched to individual patient characteristics and preferences and must recognize the potential challenge of reconciling patient and practitioner perceptions;
* right venue emphasizes that some settings are better suited in terms of safety and efficiency to delivering a specific type of care than others;
* right time indicates care is delivered in a timely manner consistent with agreed upon bench marks.
It is essential to appreciate that the "right cost" is a consequence of providing the right care, that it is an outcome rather than an input. In other words, if all five components above are present, high quality care will have been delivered with the appropriate use of resources, that is, at the right cost. Equally, however, it should be cautioned that right cost may not necessarily be the affordable cost. For example, a new drug or imaging technology may offer small but demonstrable advantages over older practices, but at an enormous increase in cost. Some might argue that right care includes the use of the newer drug or technology, while others would contend the excessive opportunity costs must be taken into consideration such that the older practices remain the right care.
An Evolving Canadian Perspective from 1996 to 2013
In a pioneering paper from 1996 Lavis and Anderson wrote:
...there are two distinct types of appropriateness: appropriateness of a service and appropriateness of the setting in which care is provided. The differences between the two parallel the differences between two other concepts in health care: effectiveness and cost-containment...An appropriate service is one that is expected to do more good than harm for a patient with a given indication...The appropriateness of the setting in which care is provided is related to cost effectiveness2.
This very serviceable definition moved beyond a narrow clinical conception based solely on the therapeutic impact of an intervention on a patient, to broader contextual consideration focused on venue. Thus, for example, the care provided appropriately in a home-care setting might not be at all appropriate if given in a tertiary care hospital. Significantly, the authors added this important observation: "Setting is a proxy measure of the resources used to provide care"2. This sentence is an invitation to expand the original Lavis and Anderson definition to encompass other resources and inputs identified over the ensuing decades. Three elements are especially important.
Timeliness became an issue in Canadian health care just as the Lavis and Anderson paper appeared. In 1997 almost two-thirds of polled Canadians felt surgical wait times were excessive, up from just over half of respondents a year earlier3. By 2004 concern with wait times was sufficiently pervasive that when the federal government and the provinces concluded the First Ministers' Agreement, it included obligations to provide timely access to cancer care, cardiac care, diagnostic imaging, joint replacement and sight restoration4. These rapid developments indicate that timeliness was now considered an essential element in determining the appropriateness of care.
A second theme that became prominent in health care over the last two decades was the concept of patient-centredness. When the Canadian Medical Association released its widely endorsed Health Care Transformation in Canada in 2010, the first principle for reform was building a culture of patient-centred care. Succinctly put, this meant that "health care services are provided in a manner that works best for patients"5. To begin the process of operationalizing this concept CMA proposed a Charter for Patient-centred Care. Organized across seven domains, it included the importance of: allowing patients to participate fully in decisions about their care; respecting confidentiality of health records; and ensuring care provided is safe and appropriate. This sweeping vision underscores the fact that care which is not matched to the individual patient cannot be considered appropriate care.
A third significant development over the last two decades was heightened awareness of the importance of scopes of practice. This awareness arose in part from the emphasis placed on a team approach in newer models of primary care6, but also from the emergence of new professions such as physician assistants, and the expansion of scopes of practice for other professionals such as pharmacists7. As the same health care activity could increasingly be done by a wider range of health professionals, ensuring the best match between competence required and the service provided became an essential element to consider when defining appropriateness. Under-qualified practitioners could not deliver quality care, while overly-qualified providers were a poor use of scarce resources.
To summarize, as a recent scoping review suggested, for a complete conceptualization of appropriateness in 2013 it is necessary to add the right time, right patient and right provider to the previously articulated right care and right setting8.
Why Appropriateness Matters
The most frequent argument used to justify policy attention to appropriateness is health system cost. There is a wealth of evidence that inappropriate care - avoidable hospitalizations, for example, or alternative level of care patients in acute care beds - is wide spread in Canada9; eliminating this waste is critical to system sustainability. In Saskatchewan, for example, Regina and Saskatoon contracted in 2011 with private clinics to provide a list of 34 surgical procedures. Not only were wait times reduced, but costs were 26% lower in the surgical clinics than in hospitals for doing the same procedures10.
There is, however, an equally important issue pointing to the importance of ensuring appropriate care: sub-optimal health care quality. In the United States, for example, a study evaluated performance on 439 quality indicators for 30 acute and chronic conditions. Patients received 54.9% of recommended care, ranging from a high of 78.7% for senile cataracts to 10.5% for alcohol dependence11. A more recent Australian study used 522 quality indicators to assess care for 22 common conditions. Patients received clinically appropriate care in 57% of encounters, with a range from 90% for coronary artery disease to 13% for alcohol dependence12. While no comparable comprehensive data exist for Canada, it is unlikely the practices in our system depart significantly from peer nations. Focusing on appropriateness of care, then, is justified by both fiscal and quality concerns.
Methodology: the Challenge of Identifying Appropriateness
While there is a clear need to address appropriateness - in all its dimensions - the methods by which to assess the appropriateness of care are limited and, to date, have largely focused on the clinical aspect.
The most frequently used approach is the Rand/University of California Los Angeles (Rand) method. It provides panels of experts with relevant literature about a particular practice and facilitates iterative discussion and ranking of the possible indications for using the practice. Practices are labeled appropriate, equivocal or inappropriate13. A systematic review in 2012 found that for use on surgical procedures the method had good test-retest reliability, interpanel reliability and construct validity14. However, the method has been criticized for other short-comings: panels in different countries may reach different conclusions when reviewing the same evidence; validity can only be tested against instruments such as clinical practice guidelines that themselves may have a large expert opinion component2; Rand appropriateness ratings apply to an "average" patient, which cannot account for differences across individuals; and, finally, Rand ratings focus on appropriateness when a service is provided but does not encompass underuse, that is, failure to provide a service that would have been appropriate9.
The Rand method, while not perfect, is the most rigorous approach to determining clinical appropriateness yet devised. It has recently been suggested that a method based on extensive literature review can identify potentially ineffective or harmful practices; when applied to almost 6000 items in the Australian Medical Benefits Schedule, 156 were identified that may be inappropriate15. This method also presents challenges. For example, the authors of a study using Cochrane reviews to identify low-value practices note that the low-value label resulted mainly from a lack of randomized evidence for effectiveness16.
Assessing the appropriateness of care setting has focused almost exclusively on hospitals. Some diagnoses are known to be manageable in a community setting by primary care or specialty clinics. The rate of admissions for these ambulatory care sensitive conditions (ACSCs) - which fell from 459 per 100,000 population in 2001-02 to 320 per 100,00 in 2008-09 - is one way of gauging the appropriateness of the hospital as a care venue9. A second measure is the number of hospital patients who do not require either initial or prolonged treatment in an acute care setting. Proprietorial instruments such as the Appropriateness Evaluation Protocol (AEP)17or the InterQual Intensity of Service, Severity of Illness and Discharge Screen for Acute Care (ISD-AC)18 have been used to assess the appropriateness of hospital care for individual patients. While these instruments have been applied to Canadian hospital data19,20, there is a lack of consensus in the literature as to the reliability and utility of such tools21-23.
Benchmarks exist for appropriate wait times for some types of care in Canada through the work of the Wait Time Alliance4. These include: chronic pain, cancer care, cardiac care, digestive health care, emergency rooms, joint replacement, nuclear medicine, radiology, obstetrics and gynecology, pediatric surgery, plastic surgery, psychiatric illness, and sight restoration. The recommendations are based on evidence-informed expert opinion.
The other two domains of appropriateness - right patient, right provider - as yet have no objective tools by which to assess appropriateness.
Determining appropriateness demands a complex and time-consuming approach, and its operationalization faces a number of barriers.
The availability of some health care services may be subject to political influence which will over-ride appropriateness criteria. For example, recommendations to close smaller hospitals deemed to be redundant or inefficient may not be implemented for political reasons.
Patient expectations can challenge evidence-based appropriateness criteria. In a primary care setting, for instance, it may be difficult to persuade a patient with an ankle sprain that an x-ray is unlikely to be helpful. The insistence by the patient is compounded by an awareness of potential legal liability in the event that clinical judgment subsequently proves incorrect. Choosing Wisely Canada recommends physicians and patients become comfortable with evidence-informed conversations about potentially necessary care24.
Traditional clinical roles are difficult to revise in order to ensure that care is provided by the most appropriate health professional. This is especially true if existing funding silos are not realigned to reflect the desired change in practice patterns.
Finally, and perhaps most importantly, even if agreed upon appropriateness criteria are developed, holding practitioners accountable for their application in clinical practice is extremely difficult due to data issues25. Chart audits could be conducted to determine whether appropriateness criteria were met when specific practices were deployed, but this is not feasible on a large scale. Rates of use of some practices could be compared among peers from administrative data; however, variation in practice population might legitimately sustain practice variation. For diagnostic procedures it has been suggested that the percentage of negative results is an indicator of inappropriate use; however, most administrative claim databases would not include positive or negative test result data26. This data deficit must be addressed with health departments and regional health authorities.
There are several additional constraints on the use of the concept by health system managers.
First, the vast majority of practices have never been subject to the Rand or any other appropriateness assessment. Even for surgical procedures clinical appropriateness criteria exist for only 10 of the top 25 most common inpatient procedures and for 6 of the top 15 ambulatory procedures in the United States. Most studies are more than 5 years old27.
Second, while the notion is perhaps appealing to policy makers, it is incorrect to assume that high use of a practice equates with misuse: when high-use areas are compared to low use areas, the proportion of inappropriate use has consistently been shown to be no greater in the high-use regions28,29.
Finally, it is uncertain how large a saving can be realized from eliminating problematic clinical care. For example, a US study modeling the implementation of recommendations for primary care found that while a switch to preferentially prescribing generic drugs would save considerable resources, most of the other items on the list of questionable activities "are not major contributors to health care costs"30. What is important to emphasize is that even if dollars are not saved, by reducing inappropriate care better value will be realized for each dollar spent.
These methodological and other challenges31 notwithstanding, the Canadian Medical Association puts forward the following recommendations for operationalizing the concept of appropriateness and of clinical practice.
1. Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
Jurisdictions should develop a framework32 for identifying potentially inappropriate care, including under-use. This involves selecting criteria by which to identify and prioritize candidates for assessment; developing and applying a robust assessment methodology; and creating mechanisms to disseminate and apply the results. Frameworks must also include meaningful consideration of care venue, timeliness, patient preferences and provider scope of practice. International examples exist for some aspects of this exercise and should be adapted to jurisdictional circumstances. Necessarily, a framework will demand the collection of supporting data in a manner consistent with the following 2013 General Council resolution:
The Canadian Medical Association supports the development of data on health care delivery and patient outcomes to help the medical profession develop an appropriateness framework and associated accountability standards provided that patient and physician confidentiality is maintained.
2. Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
Both trainees and practicing physicians should have access to education and guidance on the topic of appropriateness and on practices that are misused, under-used, or over-used. Appropriately designed continuing education has been shown to alter physician practice. Point of care guidance via the electronic medical record offers a further opportunity to alert clinicians to practices that should or should not be done in the course of a patient encounter33.
An initiative co-led by the Canadian Medical Association that is designed to educate the profession about the inappropriate over use of diagnostic and therapeutic interventions is Choosing Wisely Canada. The goal is to enhance quality of care and only secondarily to reduce unnecessary expenditures. It is an initiative consistent with the intent of two resolutions from the 2013 General Council:
The Canadian Medical Association will form a collaborative working group to develop specialty-specific lists of clinical tests/interventions and procedures for which benefits have generally not been shown to exceed the risks.
The Canadian Medical Association believes that fiscal benefits and cost savings of exercises in accountability and appropriateness in clinical care are a by-product rather than the primary focus of these exercises.
3. Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
Practitioners should be provided with incentives to eliminate inappropriate care. These incentives may be financial - delisting marginal activities or providing bonuses for achieving utilization targets for appropriate but under-used care. Any notional savings could also be flagged for reinvestment in the health system, for example, to enhance access. Giving physicians the capacity to participate in audit and feedback on their use of marginal practices in comparison to peers generally creates a personal incentive to avoid outlier status. Public reporting by group or institution may also move practice towards the mean30. In any such undertakings to address quality or costs through changes in practice behaviour it is essential that the medical profession play a key role. This critical point was captured in a 2013 General Council resolution:
The Canadian Medical Association will advocate for adequate physician input in the selection of evidence used to address costs and quality related to clinical practice variation.
When appropriateness is defined solely in terms of assessing the clinical benefit of care activities it can provide a plausible rational for "disinvestment in" or "delisting of" individual diagnostic or therapeutic interventions. However, such a narrow conceptualization of appropriateness cannot ensure that high quality care is provided with the optimal use of resources. To be truly useful in promoting quality and value appropriateness must be understood to mean the right care, provided by the right provider, to the right patient, in the right venue, at the right time.
Achieving these five components of health care will not be without significant challenges, beginning with definitions and moving on to complex discussions on methods of measurement. Indeed, it may prove an aspirational goal rather than a completely attainable reality. But if every encounter in the health system - a hospitalization, a visit to a primary care provider, an admission to home care - attempted to meet or approximate each of the five criteria for appropriateness, a major step towards optimal care and value will have been achieved across the continuum. Viewed in this way, appropriateness has the capacity to become an extraordinarily useful organizing concept for positive health care transformation in Canada.
Approved by CMA Board on December 06, 2014
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2. Lavis JN, Anderson GM. Appropriateness in health care delivery: definitions, measurement and policy implications. CMAJ. 1996;154(3):321-8.
3. Sanmartin C, Shortt SE, Barer ML, Sheps S, Lewis S, McDonald PW. Waiting for medical services in Canada: lots of heat, but little light. CMAJ. 2000;162(9):1305-10.
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6. Canadian Medical Association. CMA Policy: Achieving Patient-centred Collaborative Care. Ottawa: Canadian Medical Association; 2008.
7. Maxwell-Alleyne A, Farber A. Pharmacists' expanded scope of practice: Professional obligations for physicians and pharmacists working collaboratively. Ont Med Rev. 2013;80(4):17-9.
8. Sanmartin C, Murphy K, Choptain N, et al. Appropriateness of healthcare interventions: concepts and scoping of the published literature. Int J Technol Assess Health Care. 2008;24(3)342-9.
9. Canadian Institute for Health Information. Health Care in Canada 2010. Ottawa: CIHI; 2010.
10. MacKinnon J. Health Care Reform from the Cradle of Medicare. Ottawa: Macdonald-Laurier Institute; 2013.
11. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. NEJM. 2003;348(26):2635-45.
12. Runciman WB, Hunt TD, Hannaford NA, et al. CareTrack: assessing the appropriateness of health care delivery in Australia. Med J Aust. 2012;197(2):100-5.
13. Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care. 1986;2(1):53-63.
14. Lawson EH, Gibbons MM, Ko CY, Shekelle PG. The appropriateness method has acceptable reliability and validity for assessing overuse and underuse of surgical procedures. J Clin Epidemiol. 2012;65(11):1133-43.
15. Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556-60.
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21. Kalant N, Berlinguet M, Diodati JG, Dragatakis L, Marcotte F. How valid are utilization review tools in assessing appropriate use of acute care beds? CMAJ. 2000;162(13):1809-13.
22. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A systematic review of methods and results. Health policy. 2000;53(3):157-84.
23. Vetter N. Inappropriately delayed discharge from hospital: what do we know? BMJ. 2003;326(7395):927-8.
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Racism is a structural determinant of health and drives health and social inequities. The recent incidents of anti-Black violence, racism and discrimination in the US and Canada also shed light on the structural inequities and racism that exist within the medical profession and the health system.
The profession of medicine is grounded in respect for all people. This commitment recognizes that everyone has equal and inherent worth, the right to be valued and respected, and the right to be treated with dignity.
It’s critical that our medical culture – and society more broadly – upholds these values. But today, we’re reminded that there’s much more to do as a profession, and as a global community, to get us there.
Earlier this year, we launched our first-ever policy on equity and diversity in medicine Opens in a new window to help break down the many broad and systemic barriers that remain, to reduce discrimination and bias within our profession, and to create physically and psychologically safe environments for ourselves, our colleagues and our patients.
Alongside this policy comes a commitment to holding ourselves accountable to recognizing and challenging behaviours, practices and conditions that hinder equity and diversity, including racism.
Instances of racism, intolerance, exclusion, violence and discrimination have no place in medicine, and no place in our society. The Canadian Medical Association condemns racism in all its forms. Today, we stand alongside all those who have been affected by these appalling and inexcusable actions and beliefs.
Dr. Sandy Buchman
President, Canadian Medical Association
The current global pandemic caused by the novel coronavirus has presented the international medical community with unprecedented ethical challenges. The most difficult of these has involved making decisions about access to scarce resources when demand outweighs capacity.
In Canada, it is well accepted that everyone should have an equal opportunity to access and receive medical treatment. This is possible when there are sufficient resources. But in contexts of resource scarcity, when there are insufficient resources, difficult decisions have to be made about who receives critical care (e.g., ICU beds, ventilators) by triaging patients. Triage is a process for determining which patients receive treatment and/or which level of care under what circumstances in contexts of resource scarcity. Priority-setting for resource allocation becomes more ethically complex during catastrophic times or in public health emergencies, such as today’s COVID-19 pandemic, when there is a need to manage a potential surge of patients.
Physicians from China to Italy to Spain to the United States have found themselves in the unfathomable position of having to triage their most seriously ill patients and decide which ones should have access to ventilators and which should not, and which allocation criteria should be used to make these decisions. While the Canadian Medical Association hopes that Canadian physicians will not be faced with these agonizing choices, it is our intent, through this framework, to provide them with guidance in case they do and enable them to make ethically justifiable informed decisions in the face of difficult ethical dilemmas. Invoking this framework to ground decisions about who has access to critical care and who does not should only be made as a last resort. As always, physicians should carefully document their clinical and ethical decisions and the reasoning behind them.
Generally, the CMA would spend many months in deliberations and consultations with numerous stakeholders, including patients and the public, before producing a document such as this one. The current situation, unfortunately, did not allow for such a process. We have turned instead to documents, reports and policies produced by our Italian colleagues and ethicists and physicians from Canada and around the world, as well as provincial level documents and frameworks.
The CMA is endorsing and recommending that Canadian physicians use the guidance provided by Emmanuel and colleagues in the New England Journal of Medicine article dated from March 23rd, as outlined below. We believe these recommendations represent the best current approach to this situation, produced using the highest current standard of evidence by a panel of internationally recognized experts. We also recognize that the situation is changing constantly, and these guidelines may need to be updated as required.
The CMA will continue to advocate for access to personal protective equipment, ventilators and ICU equipment and resources. We also encourage physicians to make themselves aware of any relevant provincial or local documents, and to seek advice from their regulatory body or liability protection provider. It should be noted that some provinces and indeed individual health care facilities will have their own protocols or frameworks in place. At the time of its publication, this document was broadly consistent with those protocols that we were given an opportunity to review.
The CMA recognizes that physicians may experience moral distress when making these decisions. We encourage physicians to seek peer support and practice self-care. In addition, the CMA recommends that triage teams or committees be convened where feasible in order to help separate clinical decision making from resource allocation, thereby lessening the moral burden being placed on the individual physician.
The CMA recommends that physicians receive legal protection to ensure that they can continue providing needed care to patients with confidence and support and without fear of civil or criminal liability or professional discipline. In this time of uncertainty, physicians should be reassured that their good faith efforts to provide care during such a crisis will not put them at increased medical-legal risk. Providing such reassurance is needed so that physicians have the confidence to continue to provide care to their patients.
Recommendation 1: In the context of a pandemic, the value of maximizing benefits is most important. This value reflects the importance of responsible stewardship of resources: it is difficult to justify asking health care workers and the public to take risks and make sacrifices if the promise that their efforts will save and lengthen lives is illusory. Priority for limited resources should aim both at saving the most lives and at maximizing improvements in individuals’ post-treatment length of life. Saving more lives and more years of life is a consensus value across expert reports. It is consistent both with utilitarian ethical perspectives that emphasize population outcomes and with nonutilitarian views that emphasize the paramount value of each human life. There are many reasonable ways of balancing saving more lives against saving more years of life; whatever balance between lives and life-years is chosen must be applied consistently.
Limited time and information in a Covid-19 pandemic make it justifiable to give priority to maximizing the number of patients that survive treatment with a reasonable life expectancy and to regard maximizing improvements in length of life as a subordinate aim. The latter becomes relevant only in comparing patients whose likelihood of survival is similar. Limited time and information during an emergency also counsel against incorporating patients’ future quality of life, and quality-adjusted life-years, into benefit maximization. Doing so would require time-consuming collection of information and would present ethical and legal problems. However, encouraging all patients, especially those facing the prospect of intensive care, to document in an advance care directive what future quality of life they would regard as acceptable and when they would refuse ventilators or other life-sustaining interventions can be appropriate.
Operationalizing the value of maximizing benefits means that people who are sick but could recover if treated are given priority over those who are unlikely to recover even if treated and those who are likely to recover without treatment. Because young, severely ill patients will often comprise many of those who are sick but could recover with treatment, this operationalization also has the effect of giving priority to those who are worst off in the sense of being at risk of dying young and not having a full life.
Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justifiable and that patients should be made aware of this possibility at admission. Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better prognosis will be extremely psychologically traumatic for clinicians — and some clinicians might refuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient’s consent. We agree with these guidelines that it is the ethical thing to do. Initially allocating beds and ventilators according to the value of maximizing benefits could help reduce the need for withdrawal.
Recommendation 2: Irrespective of Recommendation 1, Critical Covid-19 interventions — testing, PPE, ICU beds, ventilators, therapeutics, and vaccines — should go first to front-line health care workers and others who care for ill patients and who keep critical infrastructure operating, particularly workers who face a high risk of infection and whose training makes them difficult to replace. These workers should be given priority not because they are somehow more worthy, but because of their instrumental value: they are essential to pandemic response. If physicians and nurses and RTs are incapacitated, all patients — not just those with Covid-19 — will suffer greater mortality and years of life lost. Whether health workers who need ventilators will be able to return to work is uncertain but giving them priority for ventilators recognizes their assumption of the high-risk work of saving others. Priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff — as has already happened for testing. Such abuses will undermine trust in the allocation framework.
Recommendation 3: For patients with similar prognoses, equality should be invoked and operationalized through random allocation, such as a lottery, rather than a first-come, first-served allocation process. First-come, first-served is used for such resources as transplantable kidneys, where scarcity is long-standing, and patients can survive without the scarce resource. Conversely, treatments for coronavirus address urgent need, meaning that a first-come, first-served approach would unfairly benefit patients living nearer to health facilities. And first-come, first-served medication or vaccine distribution would encourage crowding and even violence during a period when social distancing is paramount. Finally, first-come, first-served approaches mean that people who happen to get sick later on, perhaps because of their strict adherence to recommended public health measures, are excluded from treatment, worsening outcomes without improving fairness. In the face of time pressure and limited information, random selection is also preferable to trying to make finer-grained prognostic judgments within a group of roughly similar patients.
Recommendation 4: Prioritization guidelines should differ by intervention and should respond to changing scientific evidence. For instance, younger patients should not be prioritized for Covid-19 vaccines, which prevent disease rather than cure it, or for experimental post- or pre-exposure prophylaxis. Covid-19 outcomes have been significantly worse in older persons and those with chronic conditions. Invoking the value of maximizing saving lives justifies giving older persons priority for vaccines immediately after health care workers and first responders. If the vaccine supply is insufficient for patients in the highest risk categories — those over 60 years of age or with coexisting conditions — then equality supports using random selection, such as a lottery, for vaccine allocation. Invoking instrumental value justifies prioritizing younger patients for vaccines only if epidemiologic modeling shows that this would be the best way to reduce viral spread and the risk to others.
Epidemiologic modeling is even more relevant in setting priorities for coronavirus testing. Federal guidance currently gives priority to health care workers and older patients but reserving some tests for public health surveillance could improve knowledge about Covid-19 transmission and help researchers target other treatments to maximize benefits.
Conversely, ICU beds and ventilators are curative rather than preventive. Patients who need them face life-threatening conditions. Maximizing benefits requires consideration of prognosis — how long the patient is likely to live if treated — which may mean giving priority to younger patients and those with fewer coexisting conditions. This is consistent with the Italian guidelines that potentially assign a higher priority for intensive care access to younger patients with severe illness than to elderly patients. Determining the benefit-maximizing allocation of antivirals and other experimental treatments, which are likely to be most effective in patients who are seriously but not critically ill, will depend on scientific evidence. These treatments may produce the most benefit if preferentially allocated to patients who would fare badly on ventilation.
Recommendation 5: People who participate in research to prove the safety and effectiveness of vaccines and therapeutics should receive some priority for Covid-19 interventions. Their assumption of risk during their participation in research helps future patients, and they should be rewarded for that contribution. These rewards will also encourage other patients to participate in clinical trials. Research participation, however, should serve only as a tiebreaker among patients with similar prognoses.
Recommendation 6: There should be no difference in allocating scarce resources between patients with Covid-19 and those with other medical conditions. If the Covid-19 pandemic leads to absolute scarcity, that scarcity will affect all patients, including those with heart failure, cancer, and other serious and life-threatening conditions requiring prompt medical attention. Fair allocation of resources that prioritizes the value of maximizing benefits applies across all patients who need resources. For example, a doctor with an allergy who goes into anaphylactic shock and needs life-saving intubation and ventilator support should receive priority over Covid-19 patients who are not frontline health care workers.
Approved by the CMA Board of Directors April 2020
Organ and Tissue Donation and Transplantation (OTDT) is a rapidly changing area of medical science and practice. Organ and tissue transplantations represent significant lifesaving and life-enhancing interventions that require careful consideration by multiple stakeholders spanning medical disciplines. Technological and pharmacological advancements have made organ and tissue transplantation increasingly viable for treating related medical conditions. Changing social norms have also led to shifting perceptions of the acceptability of organ and tissue donation. Within this context, there is a need for renewed consideration of the ethical issues and principles guiding organ and tissue donation and transplantation in Canada.
The overarching principle that guides OTDT is public trust, which requires that the expressed intent either for or against donation will be honoured and respected within the donation and medical systems, and that the best interests of the potential donor are always of paramount importance; policies and mechanisms that guide OTDT should aim to maintain and foster that public trust. The CMA acknowledges and respects the diverse viewpoints, backgrounds, and religious views of physicians and patients and therefore encourages physicians to confront challenges raised by OTDT in a way that is consistent with both standards of medical ethics and patients’ values and beliefs.
This policy identifies foundational principles to address the challenges surrounding deceased and living donation. In conjunction with applicable laws and regulations in Canada, the Declaration of Istanbul, the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, and leading clinical practices this policy aims to inform physicians and other interested parties on the guiding principles of OTDT in Canada. This policy is intended to address OTDT in adult populations; the challenges, considerations, legislation, and policy surrounding pediatric and neonatal OTDT are unique and deserve focused attention.
Physicians should be aware of relevant legislation, regulatory requirements, and policies in the jurisdiction in which they practice. Physicians are encouraged to refer to the various Canadian specialty societies that deal directly with OTDT for up-to-date information and policy, as well as innovative techniques and approaches.
The practice of OTDT is of great value to patients and society. The CMA supports the continued development of greater capacity, efficiency, and accessibility in OTDT systems in co-ordination with comprehensive and compassionate end-of-life care for Canadians while acknowledging the importance of justice, informed consent, beneficence, and confidentiality to this practice.
There is a continuous need to improve the efficiency and effectiveness of OTDT in an effort to narrow the gap between demand and supply in what remains a scarce, lifesaving resource. The principle of justice should continue to guide the equitable allocation of organs and tissues in a manner that is externally justifiable, open to public scrutiny, and balances considerations of fairness (e.g., medical need or length of time on the wait-list) with medical utility (e.g., transplantation success). There should be no discrimination based on social status or perceived social worth. Lifestyle or behavioral factors should only be considered when clear evidence indicates that those factors will impact the medical probability of success. OTDT should also not rely on the patient’s ability to pay; such actions are inconsistent with the principles that underlie Canada’s publicly-funded health system. Of note, living donation to a loved one or acquaintance (via a directed donation) is regarded as ethically acceptable if potential donors are informed of all options, including that of donating in a non-directed fashion.
All levels of government should continue to support initiatives to improve the OTDT system, raise public awareness through education and outreach campaigns, and fund ongoing research, such that any Canadian who may wish to donate their tissues or organs are given every reasonable opportunity to do so. Potential donor identification and referral, while legislated in many jurisdictions, is an important area of continued development as failure to identify donors deprives families of the opportunity to donate and deprives patients of potential transplants.
To diminish inequities in the rates of organ donation between jurisdictions, federal and provincial governments should engage in consultations with a view to implementing a coordinated, national strategy on OTDT that provides consistency and clarity on medical and legal standards of informed consent and determination of death, and institutes access to emerging best practices that support physicians, providers, and patients. Efforts should be made to ensure adequate engagement with potential donors from communities that have historically had lower living donor rates to help reduce inequities in access to living donation. Policymakers should also continue to explore and appraise the evidence on policy interventions to improve the rates of organ donation in Canada – for example, see a brief overview of opt-in vs. opt-out donation systems in the background to this policy.
2. INFORMED CONSENT AND VOLUNTARINESS
Organ and tissue donation must always be an autonomous decision, free of undue pressure or coercion. By law, the potential organ donor, or their substitute decision-maker, must provide informed consent. Physicians should direct patients to appropriate resources if that patient has expressed interest to become a donor after their death. If a potential donor has not made an expression of intent for or against donation, substitute decision-makers, families, or loved ones may be approached to provide authorization for donation. It should also be noted that consent indicates a willingness to donate, but that donation itself hinges on factors such as medical suitability and timing.
End-of-life decisions must be guided by an individual's values and religious or philosophical beliefs of what it means to have a meaningful life and death. The autonomy of an individual should always be respected regarding their wish, intent, or registered commitment to become a donor after death. Input from family and loved-ones should always be considered in the context of the potential donor’s wishes or commitments – these situations must be handled on a case-by-case basis with respect for cultural and religious views while maintaining the autonomously expressed wishes of the potential donor. Physicians should make every reasonable effort to be aware and considerate of the cultural and religious views of their patients as they pertain to OTDT. Likewise, Canadian medical schools, relevant subspecialties, and institutions should provide training and continuing professional development opportunities on OTDT, including both medicolegal implications and cultural competency.
To protect the voluntariness of the potential donor’s decision, public appeals to encourage altruistic donation should not seek to compensate potential donors through payment and should not subvert established systems of organ allocation. Any exploitation or coercion of a potential donor must be avoided. However, remuneration from officially sanctioned sources for the purpose of reimbursement of costs associated with living donation (e.g., transfer to another location or lost wages during the procedure), may be considered when no party profits financially from the exchange. The CMA supports proposed amendments to the Criminal Code and the Immigration and Refugee Protection Act that criminalizes or otherwise seeks to prevent the coercive collection and transplantation of organs domestically and internationally (i.e., organ trafficking – see relevant guidelines on trafficking ). The CMA also discourages Canadians from participating in organ tourism as either a recipient or donor; physicians should not take part in transplantation procedures where it is reasonable to suspect that organs have been obtained without the donor’s informed consent or where the donor received payment (from WHO Guiding Principle 7); however, in accordance with physicians’ commitment to the well-being of the patient and the professional responsibilities relating to the patient-physician relationship in the CMA Code of Ethics and Professionalism, physicians have an obligation to treat a post-tranplant patient if requested after the patient has participated in organ tourism; physicians should be aware of any legal or regulatory obligations they may have to report a patient’s organ tourism to national authorities, taking into consideration their duties of privacy and confidentiality to the patient. ,
3. BALANCING BENEFICENCE AND NON-MALEFICENCE
Balancing beneficence and non-maleficence means to: Consider first the well-being of the patient; always act to benefit and promote the good of the patient; provide appropriate care and management across the care continuum; take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm occurs; recognize the balance of potential benefits and harms associated with any medical act; and act to bring about a positive balance of benefits over harms.
Prospective donors can benefit from the knowledge that they can potentially save lives after their own deaths. However, potential donors must not be harmed by the act of donating. In accordance with the Dead Donor Rule, organ or tissue procurement should never be the cause of death. Moreover, the care of the dying patient must never be compromised by the desire to protect organs for donation or expedite death to allow timely organ retrieval. Physicians determining that a potential donor has died should not be directly involved in tissue or organ removal from the donor or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipients of such tissues and organs (from WHO Guiding Principle 2). Leading clinical criteria, in conjunction with legally prescribed definitions of death and procedures, should inform the determination of death before donation procedures are initiated.
DCD should be practiced in compliance with the regulations of individual transplant centers, relevant legislation, and leading Canadian clinical guidelines including the national recommendations for donation after cardiocirculatory death in Canada and the guidelines for the withdrawal of life-sustaining measures. Patients undergoing medical assistance in dying (MAiD) may also be eligible for organ and tissue donation – see relevant policy guidelines.
Living donors are motivated to act primarily for the benefit of the recipient. The perceived acceptability of living donation varies from person to person; living donation is deemed to be ethically acceptable when the potential benefits outweigh the potential risks of living donation; living donation is not ethically acceptable where there is a material risk of death of the donor; living donors must provide informed consent, meet medical and psychological requirements, and receive appropriate follow-up care. It is not necessary for the potential donor to be biologically or emotionally related to the recipient.
4. CONFIDENTIALITY AND PRIVACY
Current practice protects the privacy of both donor and recipient and does not allow donation teams, organ donation organizations, or transplant teams to inform either party of the other’s identity. The continuation of this practice is encouraged at the present time to protect the privacy of both donors and recipients. In addition, healthcare providers should consider the privacy and confidentiality implications of practices employed throughout the assessment and post-operative periods – patient consent should be obtained for practices involving any loss of privacy or confidentiality (e.g. group education sessions, etc.).
A person’s choice about whether or not they intend to donate organs and tissues after their death is individual and, like other health-related information, should be considered private. The right to privacy regarding personal health information extends beyond the declaration of death.
Whenever possible, potential donor and recipients should be cared for and evaluated by separate medical teams. In the case of non-directed donations, it may be necessary for information to be shared between donor and recipient teams (e.g. recipient’s underlying disease and risk for recurrence); however, such information should be limited to what is necessary for making an informed choice. Conversely, the CMA recognizes that the choice and process of directed donation is one that is deeply personal, which is likely to result in the intersection of both donor and recipient pathways of care. In such cases, the same onus of confidentiality may not apply given the choices of the donor and recipient involved.
Approved by the CMA Board of Directors December 2019